Abstract:

Objective To investigate the efficacy and safety of fospropofol disodium （FP） in the induction and maintenance of general anesthesia in the adult patients graded Ⅰ or Ⅱ by the American Society of Anesthesiologists （ASA） undergoing elective surgery， and to provide the theoretical basis for application of EP in the induction and maintenance of general anesthesia. Methods Adult patients of ASA grade Ⅰ or Ⅱ undergoing elective surgery were selected with a total of 100 patients recruited sequentially according to the time of visit， and they were randomly divided into FP group （50 cases） and propofol group （50 cases）. All patients were prepared preoperatively， and received a slow injection of midazolam （2 to 3 mg） and sufentanil （0.3 μg·kg^-1）， followed by induction of anaesthesia 1 to 2 min later. The patients in FP group were given FP （10.0-12.5 mg·kg^-1） intravenously， and the patients in propofol group were given propofol （1.5-2.0 mg·kg^-1） intravenously. After the Modified Obserational Assessment Alertness/Sedation （MOAA/S） score dropped to 1， muscle relaxant was administrated and the induction was completed. During the maintenance of anaesthesia， the patients in FP group received a continuous intravenous infusion of FP at a rate of 12.5-15.0 mg·kg^-1·h^-1， and the patients in propofol group received a continuous infusion of propofol at a starting rate of 6 mg·kg^-1·h^-1. The patients in two groups additionally received remifentanil （0.1-0.4 μg·kg^-1·min^-1） for co-analgesia， and the rate of administration was adjusted according to the patient’s status. Systolic blood pressure （SBP）， diastolic blood pressure （DBP）， mean arterial pressure （MAP）， heart rate （HR） and bispectral index （BIS） values of the patients in two groups were recorded at different time points： before induction （T₁）， immediately after tracheal intubation （T₂）， 5 min after induction （T₃）， 10 min after induction （T₄）， 20 min after induction （T₅）， 30 min after induction （T₆）， 40 min after induction （T₇） and at the end of the procedure （T₈）. The time to onset of sedation/anaesthesia （MOAA/S≤1）， the time to eye opening， and the time to awakening （MOAA/S=5） of the patients in two groups were recorded. The lowest intraoperative SBP and BIS values and the time required of the patients in two groups were observed. The incidence of adverse reactions related to agitation， choking， nausea， vomiting and cardiovascular system or respiratory system were compared between two groups. Results There were no statistically differences in the general informations and the duration of surgery of patients between two groups （P>0.05）. The induction time of the patients in FP group （2.39 min） was significantly longer than that in propofol group （0.70 min） （P<0.05）. In the recovery period of general anesthesia， the eye opening time and recovery time of the patients in FP group were significantly longer than those in propofol group （P<0.05）. There were no significant differences in MAP of the patients between two groups at different time points （P>0.05）. The HR at T₄， T₅， T₆， and T₇ time points of the patients in FP group were lower than those in propofol group （P<0.05）. The lowest value of BIS of the patients in FP group was significantly smaller than that in propofol group， and the time taken to reach the lowest value of BIS in FP group was significantly longer than that in propofol group （P<0.05）. The time taken to reach the lowest value of SBP of the patients in FP group was longer than that in propofol group （P<0.05）. However， the lowest value of SBP of the patients and the incidence of adverse reations of the patients in two groups showed no statistical differences （P>0.05）. Conclusion Compared with propofol， FP injection is safe and effective in the induction and maintenance of general anesthesia in adult patients with ASA class Ⅰ or Ⅱ undergoing elective surgery， with a low incidence of adverse reactions， which is a new anesthesia option.

Key words: Fospropofol disodium, Propofol, Sedation, Clinical efficacy, General anesthesia